# FDA 483 - HatchMed Corporation - May 23, 2025

Source: https://www.globalkeysolutions.net/records/483/hatchmed-corporation/f48ed957-f0e8-49f4-9a1c-8e62896f14b3

> FDA 483 for HatchMed Corporation on May 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HatchMed Corporation
- Inspection Date: 2025-05-23
- Product Type: device
- Office Name: Seattle District Office
- Summary: HatchMed Corporation, a manufacturer in Kent, WA, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies in their quality system, specifically concerning the establishment and maintenance of procedures for corrective and preventive actions, purchasing controls, and equipment calibration and maintenance. These issues indicate a lack of robust quality system implementation crucial for regulatory compliance.

## Related Officers

- [Brian R. Hendricks](https://www.globalkeysolutions.net/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.globalkeysolutions.net/companies/hatchmed-corporation/7bf17844-df56-4504-a2e2-93a7f697212d

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913